NCT02279979

Brief Summary

The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
4 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 29, 2014

Last Update Submit

July 20, 2023

Conditions

Cardiogenic Shock

Keywords

PHPCardiogenic ShockPercutaneousVentricular AssistHeart PumpCatheterThoratec Corporation

Outcome Measures

Primary Outcomes (1)

  • Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2

    72 hours

Secondary Outcomes (1)

  • An assessment of major adverse events

    72 hours

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All enrolled patients will be treated with the HeartMate PHP device

Device: HeartMate PHP

Interventions

HeartMate PHPDEVICE

The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output.

Treatment Arm

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
  • Patient has a cardiac index of \< 2.2 L/min/m2 and is being treated with at least one moderate dose inotrope or at least one moderate dose of vasopressor (e.g., milrinone ≥0.3 mcg/kg/min, dopamine \> 5 mcg/kg/min, dobutamine \> 5 mcg/kg/min) AND:
  • PCWP \> 18 mmHg, AND
  • Systolic blood pressure \< 100 mmHg, AND
  • Decreased organ perfusion as evidenced by urine output of 50 mL/hr OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
  • Written, signed, and dated informed consent

You may not qualify if:

  • Patient is \>85 years of age
  • Right ventricular failure requiring mechanical circulatory support
  • ST elevation myocardial infarction (STEMI) within 30 days of procedure
  • Cardiac arrest within 7 days of procedure requiring CPR
  • Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
  • Documented acute myocarditis
  • Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
  • Hypertrophic disease or any left ventricular outflow tract obstruction
  • Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
  • Mural thrombus in the left ventricle
  • History of aortic valve replacement
  • End-stage renal disease requiring dialysis
  • Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
  • Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
  • Platelet count \< 100,000
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Na Homolce Hospital

Prague, 130 50, Czechia

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 140 21, Czechia

Location

Universitätskliniken Düsseldorf

Düsseldorf, 40225, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Erasmus Medical Center

Rotterdam, 3000-CA, Netherlands

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Pooja Chatterjee

    Thoratec LLC, St. Jude Medical, Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

DE(2)HU(1)NL(1)CZ(2)